Guest Columns

1. Why CMC Must Shape Critical Decisions Early In Development 11/11/2026

   Case studies reveal the gap between research progress and clinical readiness. In these stories, earlier CMC involvement might have saved resources and staved off delays.

2. Developing Your Vapor Phase Hydrogen Peroxide Cycle 11/10/2026

   Vapor phase hydrogen peroxide has been used for decades as a surface decontaminant in pharma/biotech, but there has been little guidance on how to establish the parameters. Here's an industry consensus from BioPhorum.

3. Closing The Gap Between Modeling And GMP Predictive Control 11/10/2026

   Predictive control offers opportunities to improve process consistency, reduce variability, and respond to changing manufacturing conditions before they cause deviations.

4. IT/OT Convergence Could Lighten Biopharma's Automation Burden 11/9/2026

   Integration lets frameworks talk to each other through middleware. Convergence brings them under the same architecture, which can can reduce costs and maintenance.

5. Beyond The Plate Count: How To Build A Defensible Environmental Monitoring Trend Review 11/6/2026

   Determining whether a drug manufacturing environment is stable, drifting, or developing a recurring loss-of-control signal requires integrated trend evaluation.

6. Want More Sustainable Biopharma Packaging? Try These Levers 11/6/2026

   Biopharmaceutical packaging optimization must not compromise the goods inside or compliance, so sustainable packaging developers might need to think outside the box.

7. How To Keep Your 'Big Bang' Platform Switch From Becoming A Big Bust 11/4/2026

   Leaders at a Roche fill/finish facility describe the tactile steps involve to change EMS, ERP, and WMS all at once with no rollback option.

8. What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI 11/4/2026

   The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.

9. How Is Your Glass Supplier Adapting To Europe's Energy Crisis? 11/3/2026

   Europe's glass manufacturers, including those making pharmaceutical lab glassware, have experienced a series of energy shocks. Many have adopted sustainability practices.

10. Fine-Tuning Bioseparation Column Geometry With 3D-Printed Monoliths 11/3/2026

    If geometric control, not retention, is the priority in viral vector separation, research group says high-resolution 3D-printing chromatography monoliths can be useful.